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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K951462
Device Name AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
Applicant
ALLERGAN MEDICAL OPTICS
9701 JERONIMO RD.
IRVINE,  CA  92618 -2020
Applicant Contact JEANNE ERICKSON
Correspondent
ALLERGAN MEDICAL OPTICS
9701 JERONIMO RD.
IRVINE,  CA  92618 -2020
Correspondent Contact JEANNE ERICKSON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/30/1995
Decision Date 06/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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